Head of Quality Compliance

We are supporting a global pharmaceutical innovator in the search for a Head of Quality Compliance to lead quality assurance operations at a flagship biologics manufacturing site in Massachusetts.

This is a pivotal, site-based leadership role, responsible for driving compliance excellence, managing regulatory interface with the FDA, and overseeing quality system performance in a complex, high-throughput environment.

As the site’s senior compliance authority, you will play a central role in shaping quality culture, leading high-performing teams, and delivering results through robust systems, strategic remediation, and operational integrity.

Key Responsibilities

• Direct all QA compliance activity at site level, ensuring alignment with FDA expectations and global cGMP standards.
• Serve as lead spokesperson during inspections and audits, driving proactive inspection readiness.
• Lead and develop a large, multi-layered quality team, with full responsibility for performance, capability building, and succession planning.
• Oversee the execution of CAPAs, change controls, deviation investigations, and site-level quality initiatives.
• Drive continuous improvement and remediation programs, applying data-driven decision-making to mitigate risk and enhance compliance.
• Collaborate with senior stakeholders across manufacturing, technical operations, and global quality functions to ensure integration of quality across operations.

Candidate Profile

• Extensive leadership experience in QA within a biologics or pharmaceutical manufacturing environment (10+ years, with 8+ in senior leadership).
• Strong track record of leading site-based compliance strategy, regulatory inspections, and cross-functional quality teams.
• Deep knowledge of FDA regulations, cGMP, and global regulatory frameworks.
• Demonstrated success in leading remediation efforts and transforming quality systems at scale.
• High-level communication and stakeholder management skills, with the ability to influence at executive level.

Why This Opportunity

This is more than a quality leadership role, it’s a strategic position at the heart of a global mission to improve lives through science.

You’ll join a collaborative, forward-thinking environment where your leadership will directly shape the future of quality and compliance at site level.